MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE GOLD; CATHETER

Model Number 5621

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing lot number was not reported.The manufacturing history could not be reviewed.If further information is received a follow-up report will be issued after the investigation is complete.

Event Description

It was reported that: physician, stated the head of a turnpike gold separated in a right coronary artery.This became embedded in the calcification and when the micro catheter was removed, the sheath literally peeled off along its entire length.The patient, meanwhile, left with this foreign body in the artery.Clinical consequences: the patient is fine despite the gold head remained in the patient.The complaint device is not available for investigation.Additional information received (b)(6) 2020: the patient, meanwhile left with this foreign body in the artery.The intervention could not happen.The medical intervention of the doctor was to remove the micro catheter.The doctor assured that he was certain this part will not move in the patient, and it is not dangerous for the patient.Md is not available for investigation.

Manufacturer Narrative

A manufacturing record review could not be completed as no lot number was provided by the account.A dvd of issue was sent for review.The turnpike tip was caught in the vessel of the rca.The angiogram showed snaring attempts done to retrieve the tip however, it was unsuccessful.It is likely that there is a dissection of the vessel per clinical review the balloon and the turnpike seem to be in different lumens of the vessel, and it is undetermined which of the catheters are in the true or false lumen.It is unknown if the tip was tethered against the wall with a stent.Stent struts aren't clearly visible in the angiogram.It is likely that the tip is lodged in the calcium post poba.Based on the fluoroscopy, part of the shaft along with the tip of the catheter was noted to be separated.It is unknown from the angiogram, if the physician rotated the tip lodged in the rca was rotated more than 2 consecutives turn in either direction and/or was used against resistance.Per ifu states the following warning: do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury.Never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Based on the angiogram, the turnpike is likely used correctly and not necessarily outside the ifu.It was noted from the account that the patient is safe, and the piece left in the rca will not move and is not dangerous.Based on the angiogram review and no product evaluation, the most likely root cause is operational context.

• Brand Name: TURNPIKE GOLD
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10525598
• MDR Text Key: 220265957
• Report Number: 2134812-2020-00059
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 70